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Efficacy of MUCIPLIQ on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering From Oral Cancer (MUCIPLIQ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01840436
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
Organ, Tissue, Regeneration, Repair and Replacement

Brief Summary:

MUCIPLIQ is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Glycosaminoglycans are involved 1) in the stabilization of cells micro-environment, known as extracellular matrix, by binding to structural proteins, and 2) in cells communication process by protecting growth factors. At the site of a lesion, glycosaminoglycans are degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By replacing damaged glycosaminoglycans, MUCIPLIQ provides a protection, and restores the matrix scaffold and cells communication, a process known as Matrix Therapy.

The purpose of this new controlled study is to determine whether MUCIPLIQ can decrease the incidence and the severity of radio-chemotherapy-induced mucositis in patients suffering of upper aerodigestive tract cancers, when used as a preventive agent.

The study's main hypothesis is that MUCIPLIQ mouthwash applications before radiotherapy would protect the healthy oral tissue against cytotoxic effect of chemotherapy and radiations.


Condition or disease Intervention/treatment Phase
Oral Mucositis Carcinoma in Situ of Upper Respiratory Tract Device: MUCIPLIQ Device: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Study Evaluating the Effect of MUCIPLIQ Versus Placebo on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering of Upper Aerodigestive Tract Carcinomas
Study Start Date : March 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
This arm receives a placebo (saline solution) mouthwash treatment twice a day.
Device: Placebo
Placebo is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.

Experimental: MUCIPLIQ 0.05 mg/mL
This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.05 mg/mL twice a day.
Device: MUCIPLIQ
MUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.

Experimental: MUCIPLIQ 0.015 mg/mL
This arm receives MUCIPLIQ mouthwash treatment at a final concentration of 0.015 mg/mL twice a day.
Device: MUCIPLIQ
MUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.




Primary Outcome Measures :
  1. Incidence of grade 2 or higher oral mucositis [ Time Frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks ]
    Differences of incidence of patients suffering of oral mucositis of grade 2 or higher


Secondary Outcome Measures :
  1. Number and Terms of grade 2 or higher oral mucositis [ Time Frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks ]
    Differences of number and terms of oral mucositis of grade 2 or higher between MUCIPLIQ and placebo groups

  2. Administered-antalgics posology and nature [ Time Frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks ]
    Differences of administered-antalgics posology and nature between MUCIPLIQ and placebo groups

  3. Pain experienced in time [ Time Frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks ]
    Differences of pain experienced by patients between MUCIPLIQ and placebo groups, assessed with Numerical Pain Scale (0 to 10).

  4. Assessment of the Oral Health Impact Profile [ Time Frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks ]
    Assessment of the Oral Health Impact Profile assessed by the OHIP-14 questionnaire between MUCIPLIQ and placebo groups

  5. Weight curve [ Time Frame: Recruitment, 2, 3, 4, 5, 6, 7 and 11 to 13 weeks ]
    Assessment of the weight curves for MUCIPLIQ and placebo groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient suffering from an upper aerodigestive tract carcinoma treated by radiotherapy alone or radiotherapy associated with a concomitant platine-salts-based chemotherapy ;
  • Patient suffering of an upper aerodigestive tract carcinoma without entrance or located in the oral cavity, in the oropharynx or in the rhinopharynx ;
  • Patient age of 18 years old or higher ;
  • Writing informed consent to participate to the trial ;
  • Patient affiliated to the French social security system.

Exclusion Criteria:

  • Treatment by non-standard fragmentation (concentrate irradiation)
  • Carcinoma located in the hypopharynx or in the larynx ;
  • Known hypersensitivity to heparinoids ;
  • Patient who already benefited from a radiotherapy treatment ;
  • Patient who already benefited from a chemotherapy treatment. Patients who benefited from neoadjuvant chemotherapy as part of their upper aerodigestive tract carcinoma care, may be included if it was held at least 4 weeks before the inclusion visit ;
  • Patient participating to another biomedical research ;
  • Pregnant woman, breastfeeding woman, parturient or likely to be ;
  • Patient deprived of freedom, under supervision or guardianship ;
  • Patient unable to attend to scheduled medical monitoring due to geographical, social or mental reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840436


Locations
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France
Centre Hospitalier Intercommunal de Créteil
Créteil, Ile de France, France, 94010
APHP - Hôpital Tenon
Paris, Ile de France, France, 75970
Institut de Cancérologie Gustave Roussy
Villejuif, Ile de France, France, 94800
Centre de Cancérologie Léon Bérard
Lyon, France, 69373
CHRU de Besançon, Site du CH Belfort-Montbéliard
Montbéliard, France, 25200
Sponsors and Collaborators
Organ, Tissue, Regeneration, Repair and Replacement
Investigators
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Principal Investigator: Nicolas Daly-Schveitzer, MD, PhD Institut Gustave Roussy, Villejuif, France
Principal Investigator: Yungan Tao, MD Institut Gustave Roussy, Villejuif, France
Study Director: Denis BARRITAULT, PhD Organ, Tissue, Regeneration, Repair and Replacement

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Responsible Party: Organ, Tissue, Regeneration, Repair and Replacement
ClinicalTrials.gov Identifier: NCT01840436    
Other Study ID Numbers: CT11M10MURT
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016
Keywords provided by Organ, Tissue, Regeneration, Repair and Replacement:
MUCIPLIQ
Matrix therapy
RGTA
Oral mucositis
Additional relevant MeSH terms:
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Carcinoma
Carcinoma in Situ
Mucositis
Stomatitis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases